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临床试验/NCT04962477
NCT04962477已完成不适用

Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Expression of viral entry factors

研究概览

简要总结

The clinical presentation of the ongoing coronavirus disease-19 (COVID-19) pandemic in pregnant women is unique with more asymptomatic infection, higher morbidity when symptomatic, yet without a difference in mortality rate. This is strikingly different from the high mortality observed during the past influenza A pandemics. Though both influenza A virus (IAV) and SARS-CoV-2 are single-stranded RNA viruses, the exquisite vulnerability of pregnant women to influenza A but not COVID-19 remains a mystery. Our objective, therefore, is to determine the mechanisms that predispose pregnant women to severe influenza A but confer protection against SARS-CoV-2 infection by examining the viral entry factors and innate immune response mechanisms in the nasal epithelium of pregnant vs. non-pregnant age-matched women.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy, uncomplicated pregnant subjects in the third trimester ((≥ 28 ≤ 41 weeks' gestation)
  • Healthy non-pregnant adult female volunteers between the ages of 18 - 45 years.
  • Between 18-45 years old
  • Able to provide consent

排除标准

  • Patients in labor
  • Critically ill patients needing intubation and mechanical ventilation
  • Patients with fever or influenza-like illness
  • H/o epistaxis or rhinosinusitis
  • Nasal polyposis and deviated nasal septum
  • Preeclampsia and chronic hypertension
  • Use of anti-hypertensives
  • Ongoing seasonal allergy
  • H/o asthma
  • Recent recovery from SARS-CoV-2 or influenza A infection (≤ 4 weeks)
  • Recent receipt of either COVID-19 or influenza A vaccine (≤ 4 weeks)
  • Use of immunosuppressive medications
  • Use of inhaled corticosteroids
  • Use of hormonal contraceptives in non-pregnant population
  • Allergy to local anesthetic

结局指标

主要结局

Expression of viral entry factors

时间窗: Dec 2021

次要结局

  • Expression of genes involved in innate immune response and host-pathogen interaction(Dec 2021)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arvind Palanisamy

Associate Professor of Anesthesiology, Obstetrics and Gynecology

Washington University School of Medicine

研究点 (1)

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